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NCT03865732 · ClinicalTrials.gov registry record · Phase 2

Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)

A Phase 2 study, sponsored by Marinus Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT03865732 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 29 participants.

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The verdict

NCT03865732, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene mutation.

Interventions

  • DRUG Placebo
  • DRUG Ganaxolone

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2019-05-17
Est. Completion 2022-06-20
Phase Phase 2

Sponsor

Marinus Pharmaceuticals

19 total trials

What the Registry Record Tells You About NCT03865732

The ClinicalTrials.gov registry entry for NCT03865732 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marinus Pharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03865732 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03865732 about?

NCT03865732 is a clinical study titled "Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)". A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene mutation.

What is the current status of trial NCT03865732?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2019-05-17. Estimated completion is 2022-06-20.

What interventions are being tested in trial NCT03865732?

The interventions under investigation include: Placebo (DRUG), Ganaxolone (DRUG).

Who is sponsoring clinical trial NCT03865732?

This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.